Phacilitate Early Development Forum 2005
Presentations
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DAY 1 | Wednesday, October 5th, 2005
Morning plenary session
Translational medicine - Strategies to increase the predictability of eventual success or failure by improving the quality of information derived in the preclinical area and applying it clinically
Chair’s introduction
Translational medicine: Definition, opportunities, challenges
Dr John Brown
Keynote address
How is the adoption of translational medicine by the pharmaceutical industry improving the efficiency of drug development?
Orest Hurko, MD
Defining the value of new techniques and technologies being used to increase predictability of success or failure earlier in the drug development cycle
Dr Holger Adelmann
SLIDES NOT AVAILABLE
Developing and validating biomarkers from preclinical to clinical Proof of Concept to support early stage decision-making
Chair’s introduction
What progress is being seen in the development of biomarkers at the early stages of development?
Dr Jochen Kuhlmann
Case study
Improving clinical inclusion criteria via plasma profiling: Differentiating Alzheimer’s Disease from mild cognitive impairment
Dr Gregory J. Opiteck
Case study
Preclinical target organ pathology to bridging safety biomarkers for the clinic
Dr Graham Betton
Case study
Circulating endothelial cells, a surrogate marker of angiogenesis and anti-angiogenic response - developing biomarkers for oncology therapy
Dr Francesco Bertolini
Case study
Critical role of biomarkers for preclinical cycle time reduction for cardiovascular drug development
Dr Jaipal Singh
Panel discussion
Evaluating progress in the development of biomarkers that completely validate or disprove a compound's efficacy
Moderator:
Dr Andrew Hughes
Workshop
Increasing the predictive value of animal studies through the use of new models
Chair’s introduction
What is being achieved in non-clinical studies to develop principles for application into man?
Dr Peter McAnulty
Case study – A focus on safety
Advantages and disadvantages of new models
Dr Klaus Olejniczak
Case study
Applications for genetically altered mice and molecular toxicology in pharmaceutical hazard identification
Dr Carl Alden
Case study
Integrated risk assessment: Predictive value of non-clinical data to humans
Dr Jean-Pierre Valentin
Case study
Application of novel transgenic models for efficacy testing, lead selection and preclinical development
Professor C. Roland Wolf
Panel discussion
Cross-species extrapolation – how do we choose the most appropriate preclinical models to predict response in humans?
NO SLIDES PRESENTED
Afternoon plenary session
Panel discussion
Overcoming key regulatory challenges to gain maximum value from safety and efficacy biomarkers
Moderator:
Dr John Brown
Panellists:
Lawrence J. Lesko, PhD, FCP
Dr Klaus Olejniczak
Orest Hurko, MD
Dr Gregory J. Opiteck
Dr Jochen Kuhlman
Dr Holger Adelmann
NO SLIDES PRESENTED
DAY TWO | Thursday, October 6th, 2005
Morning plenary session
How is preclinical and early clinical research data currently viewed and regulated by the FDA & EMEA?
Chair’s introduction
Bridging preclinical and clinical research, the need for a rethinking including industry initiatives
Dr Jørgen Dirach
SLIDES TO FOLLOW
KEYNOTE ADDRESS
What is the latest from Europe?
Dr Klaus Olejniczak
US perspective
Dr Jean-Jacques Garaud
Panel discussion
How will drug development alter as a result of earlier submission and earlier human tissue studies?
NO SLIDES PRESENTED
Main session
Advances in the use of predictive ADME/Tox to identify safety indicators earlier in the drug development process
Chair’s introduction
Advances in early drug development using emerging and newly emergent safety indicators
Dr Peter G. Lord
Case study
Investigation of the molecular mechanisms leading to drug-induced vascular injury in rats
Dr Stephan Chevalier
Case study
Metabolite profiles for detection and prediction of drug effects
Dr Hans Senn
Optional lunch briefing
Implementing automated pathology solutions for preclinical safety
Moderator: Dr Neil Dey
Divide and loose
Dr Ferdinand Rombout
Case study
Using predictive technology to increase productivity and balance risk in compound optimisation: two brief case studies
Dr Mike Tarbit
Workshop
Evaluating developments in imaging technologies and their use in more rapidly achieving Proof of Concept
Chair’s introduction
Dr Bill Vennart
Case study
Imaging sciences in the pre-clinic: Examples from efficacy studies
Dr Sudeep Chandra
Case study
Imaging tumour vascular and metabolic responses to therapy: A role for PET/CT
Professor Ken Miles
Case study
Potentials and pitfalls of clinical imaging in exploratory clinical development
Dr Liqun Wang
Case study
Utilization of flow cytometry and cellular imaging techniques to develop biomarkers and assess pharmacodynamic endpoints
Dr John Ferbas
Afternoon plenary session
Presentations & panel discussion
Developing better toxicology profiling to improve early stage safety assessment
Moderator:
Dr Peter G. Lord
NO SLIDES PRESENTED
Panellists:
Dr Ina Schuppe Koistinen
Dr Thomas Steger-Hartmann
NO SLIDES PRESENTED
Dr Johan Luthman
NO SLIDES PRESENTED
DAY THREE | Friday, October 7th, 2005
Morning plenary session
Efficiently making the translation from preclinical to phase 1 clinical development
Chair’s introduction
Dr Bruce Halpryn
NO SLIDES PRESENTED
KEYNOTE ADDRESS
Overcoming the key challenges to harness the power of translational medicine – How can we improve communication from lab to clinic, and back again?
Dr Giles Campion
Early stage R&D productivity management - a framework for improved decision making
Dr Mark Seidler
Panel discussion
Comparing various companies’ criteria for making the decision to go into the clinic
Moderator:
Dr Mark Seidler
Panellists:
Dr Bruce Halpryn
Dr Giles Campion
Dr Carl Alden
Dr Dirk Mendel
NO SLIDES PRESENTED
What steps are being taken to speed up human testing in early Phase 1?
Dr Dirk Mendel
Integration of kinetic-dynamic data in efficacy and safety evaluation of drug candidates
Dr Johan Luthman
Evaluating the predictive value of PK/PD modelling and simulation
Dr Hui C. Kimko
Case study
Benefits of having sound data in phase I/II PK-PD and dose-ranging studies
Dr Bernard Vrijens
Case study
PK/PD modelling and physiologically based approaches for PK/PD predictions in man
Thierry Lavé PhD
Evaluating the value of micro-dosing as an alternative approach to First-in-Man studies
Dr Peter Buchan
Closing panel discussion
Moderator:
Dr Peter Buchan
Panellists:
Dr Johan Luthman
NO SLIDES PRESENTED
